PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.

• K Number: K022666
• Device Name: PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.
• Manufacturer: ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
• Date Cleared: 2002-10-09 ( 61 days)
• Product Code: NEW
• Regulation Number: 878.4840
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

PDO (Polydioxanone) Monofilament Synthetic Absorbable Sutures U.S.P. are indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDO is not indicated for use in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are useful where an absorbable suture with extended wound support (up to six weeks) is desirable.

Device Description

The PDO (Polydioxanone) Monofilament Synthetic Absorbable Sutures, U.S.P. manufactured by ARC Medical and CP Medical are monofilament suture composed of a Poly(p-dioxanone) acid, un-dyed or dyed with D&C Violet No. 2.

AI/ML Overview

The device is a PDO (Polydioxanone) Monofilament Synthetic Absorbable Suture. The study evaluated its equivalence to a predicate device and adherence to USP specifications.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (USP Specifications)	Reported Device Performance (ARC Medical PDO Suture)
Suture Diameter	Meets or exceeds USP specifications
Suture Length	Meets or exceeds USP specifications
Knot Pull Tensile Strength	Meets or exceeds USP specifications
Needle Attachment Strength	Meets or exceeds USP specifications
Absorption Rate	Meets or exceeds USP specifications
Equivalence to predicate device (CP Medical MONO-DOX)	Equivalent in terms of listed parameters

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the exact sample size used for the testing. It mentions "Testing of suture diameter, suture length, knot pull tensile strength, needle attachment strength and absorption rate." The provenance of the data is that it was generated by ARC Medical Supplies (Beijing) Co., Ltd. through their own testing. It does not mention if it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This study involves physical testing of a medical device against established standards (USP specifications) and comparison to a predicate device, not expert interpretation of diagnostic images or clinical scenarios.

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication method was described or needed for this type of device testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not a diagnostic device or an AI-assisted device that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study:

Not applicable. This is a physical medical device, not an algorithm or AI system. The tests performed are standalone device performance tests.

7. Type of Ground Truth Used:

The ground truth used for this study consisted of:

• USP (United States Pharmacopeia) XXIII specifications: These are established, legally recognized standards for medical devices like sutures, defining acceptable ranges for properties such as diameter, length, strength, and absorption.
• Predicate device characteristics: The characteristics of the MONO-DOX synthetic absorbable polydioxanone surgical sutures manufactured by CP Medical were used as a comparative ground truth to demonstrate equivalence.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable as there is no training set for this type of device.

Summary

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Kozz b.i.^{24}_{6}

ARC Medical Supplies(Beijing) Co., Ltd.

OCT 0 9 2002

#66 Qian Ban Bi Jie, Xizhirnen Nei, Beijing CHINA 100035 Tel: [phone] Fax: [phone] Email: [e-mail]

Page 1 of 2

510(k) SUMMARY

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

Applicant	ARC Medical Supplies (Beijing) Co., Ltd.#66 Quian Ban Bi Jie, Xizhimen NeiBeijing, China 100035Telephone: [phone]Fax: [phone]
Contact Person	Mr. Charles F. AndrewsC.F. Andrews & Associates1591 S. Moorland Road, Suite 104New Berlin, WI 53151Telephone: [phone]Fax: [phone]
Date	August 7, 2002
Name of Device
Proprietary Name:	PDO (Polydioxanone) MonofilamentSynthetic Absorbable Suture U.S.P.
Common or Usual Name:	Polydioxanone MonofilamentSynthetic Absorbable Suture U.S.P.
Classification Name:	Suture, Absorbable, Synthetic, Polydioxanone

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Korticki

ARC Medical Supplies(Beijing) Co., Ltd.

#66 Qian Ban Bi Jie, Xizhimen Nei, Beijing CHINA 100035 Tel: [phone] Fax: [phone] Email: [e-mail]

Page 2 of 2

510(k) SUMMARY - continued

Monofilament Synthetic Absorbable Sutures. PDO (Polydioxanone) U.S.P. manufactured by ARC Medical Supplies (Beijing) Co., Ltd. are equivilent to MONO-DOX synthetic absorbable polydioxanone surgical sutures manufactured by CP Medical.

The PDO (Polydioxanone) Monofilament Synthetic Absorbable Sutures, U.S.P. manufactured by ARC Medical and CP Medical are monofilament suture composed of a Poly(p-dioxanone) acid, un-dyed or dyed with D&C Violet No. 2.

PDO (Polydioxanone) Monofilament Synthetic Absorbable Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDO is not indicated for use in adult cardiovascular tissue, microsurgery and neural These sutures are useful where an absorbable suture with extended wound tissue. support (up to six weeks) is desirable.

Testing of suture diameter, suture length, knot pull tensile strength, needle attachment strength and absorption rate according to methods outlined in U.S.P. XXIII demonstrates that ARC Medical PDO (Polydioxanone) Monofilament Synthetic Absorbable sutures meet or exceed U.S.P. specifications and are equivalent in terms of the above parameters to Synthetic Absorbable polydioxanone surgical sutures manufactured by CP Medical.

K

Richard Kuo, Chairman

P-L-Q

I Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ARC Medical Supplies (Beijing) Co., Ltd. c/o Mr. Charles F. Andrews President C.F. Andrews & Associates 1591 S. Moorland Road, Suite 104 New Berlin, Wisconsin 53151

OCT 0 9 2002

Re: K022666

Trade/Device Name: PDO (Polydioxanone) Monofilament Synthetic

Absorbable Suture Regulation Number: 21 CFR 878.4840

Regulation Name: Suture, surgical, absorbable, polydioxanone Regulatory Class: Class II Product Code: NEW Dated: August 29, 2002 Received: August 30, 2002

Dear Mr. Andrews:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Charles F. Andrews

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Styt Rlvelu

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO2266

510(k) Number : K022666

Device Name:

PDO (Polydioxanone) Monofilament Synthetic Absorbable Suture U.S.P.

Indications for Use: PDO (Polydioxanone) Monofilament Synthetic Absorbable Sutures U.S.P. are indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDO is not indicated for use in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are useful where an absorbable suture with extended wound support (up to six weeks) is desirable.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Styp Purcle

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K022666

Regulation Number and Section

§ 878.4840 Absorbable polydioxanone surgical suture.

(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.